Prediction of Progression of Age-Related Macular Degeneration
Primary Purpose
Macular Degeneration, Macular Degeneration, Wet, Macular Degeneration, Dry
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Algorithm prediction
Sponsored by
About this trial
This is an interventional diagnostic trial for Macular Degeneration
Eligibility Criteria
Inclusion Criteria:
- Non-neovascular AMD at baseline in at least one eye with no signs of GA,
- > 45 years of age,
- willingness to participate through a signed consent form.
Exclusion Criteria:
- Pregnant women and vulnerable populations
- Participation in an investigational trial that involves treatment with any drug (with the exception of vitamins or minerals) within 3 months prior to Day 1.
- Any history of macular pathology unrelated to AMD affecting vision or contributing to the presence of intraretinal or subretinal fluid
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Prediction Algorithm
Control
Arm Description
Patients in the test arm will have a screening visit, then will come for two follow-up visits, at 3 months (if the algorithm determines high-risk of conversion within 3 months) and 6 months.
Patients in the control arm will have a screening visit, then will come for one follow-up visit, at 6 months (standard care) only.
Outcomes
Primary Outcome Measures
Visual Acuity
The primary outcome measure will be the difference in visual acuity between test and control patients in those who progressed to late stage AMD
Secondary Outcome Measures
Actual risk of conversion
The actual risk/ of conversion to wet AMD will be calculated for each eye that progressed using regression analysis. This risk will be compared to the risk that the algorithm predicted.
Number of visits
Number of visits will be compared between the test arm and the control arm of patients who progression to wet AMD
Full Information
NCT ID
NCT04640649
First Posted
October 8, 2020
Last Updated
November 17, 2020
Sponsor
University of Illinois at Chicago
Collaborators
Stanford University, Illinois Retina Associates, Bascom Palmer Eye Institute
1. Study Identification
Unique Protocol Identification Number
NCT04640649
Brief Title
Prediction of Progression of Age-Related Macular Degeneration
Official Title
A Novel Approach to Personalized Prediction of Progression of Age-Related Macular Degeneration
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 2020 (Anticipated)
Primary Completion Date
July 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago
Collaborators
Stanford University, Illinois Retina Associates, Bascom Palmer Eye Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal for this study is to initiate a randomized, controlled clinical trial to test the viability of personalized AMD progression prediction models. Early and intermediate AMD patients will be recruited and randomly assigned them to a control or test group. The test group will include patients who will receive personalized follow-up care based on their predicted risk, and collect baseline and follow-up data.
This work will advance the AMD field by improving the identification of high-risk patients as candidates for more frequent screening and earlier treatment, leading to better clinical outcomes.
Detailed Description
More than 90% of patients with advanced AMD have severe vision loss. Predicting AMD progression from an early or intermediate stage is crucial, since prompt intervention after a choroidal neovascularization (CNV) event and geographic atrophy (GA) monitoring can greatly improve visual outcomes. Patients at higher risk of progression should have more frequent follow-up visits, since progression often occurs before any visual changes are noticed by the patient. Previous work has determined the risk factors for AMD progression based on drusen features in fundus photos, Optical Coherence Tomography (OCT) and from genetic factors. However, current models are limited by their ability to make predictions over short intervals, which limits their utility in guiding screening intervals.
In this study we will recruit patients with early and intermediate AMD in at least one eye who are at risk of converting to wet AMD or GA expansion. We will perform a randomized trial where we will randomly assign them to a control or test group (personalized follow-up care starting at 3 months based on their predicted risk from algorithm results), and collect baseline genetic, demographic, imaging, and clinical data and first follow-up data at the 3 month and 6 month follow-up time points. Outcomes will be measured to determine if an algorithm predicting early follow-up for high-risk patients (3 month) is advantageous over the standard 6 month follow-up time point.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Degeneration, Macular Degeneration, Wet, Macular Degeneration, Dry
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
278 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Prediction Algorithm
Arm Type
Experimental
Arm Description
Patients in the test arm will have a screening visit, then will come for two follow-up visits, at 3 months (if the algorithm determines high-risk of conversion within 3 months) and 6 months.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients in the control arm will have a screening visit, then will come for one follow-up visit, at 6 months (standard care) only.
Intervention Type
Other
Intervention Name(s)
Algorithm prediction
Intervention Description
Patients with early and intermediate AMD in at least one eye who are at risk of converting to wet AMD or GA expansion will be randomly assigned to a test group or control group. The test group will have their baseline data analyzed by an algorithm to predict the probability of conversion to wet AMD. If the probability is high for conversion at or before 3 months, patients will have earlier follow-up care than the control group (standard follow-up care every 6 months).
Primary Outcome Measure Information:
Title
Visual Acuity
Description
The primary outcome measure will be the difference in visual acuity between test and control patients in those who progressed to late stage AMD
Time Frame
one year
Secondary Outcome Measure Information:
Title
Actual risk of conversion
Description
The actual risk/ of conversion to wet AMD will be calculated for each eye that progressed using regression analysis. This risk will be compared to the risk that the algorithm predicted.
Time Frame
one year
Title
Number of visits
Description
Number of visits will be compared between the test arm and the control arm of patients who progression to wet AMD
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Non-neovascular AMD at baseline in at least one eye with no signs of GA,
> 45 years of age,
willingness to participate through a signed consent form.
Exclusion Criteria:
Pregnant women and vulnerable populations
Participation in an investigational trial that involves treatment with any drug (with the exception of vitamins or minerals) within 3 months prior to Day 1.
Any history of macular pathology unrelated to AMD affecting vision or contributing to the presence of intraretinal or subretinal fluid
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joelle A Hallak, PhD
Phone
3129960157
Email
joelle@uic.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kathleen Romond, MPH
Email
kromon2@uic.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joelle A Hallak, PhD
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Prediction of Progression of Age-Related Macular Degeneration
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